Why Should You Attend:
This webinar will cover basic requirements for the content of a Device Master Record for compliance to 21CFR 820 and ISO 13485:2016 and will review potential differences in the requirements between the two regulatory standards. It will further discuss the difference between a Device Master Record (DMR) and a Device History Record (DHR) including the differences, if any, between a device Batch Record and a Device History Record?
Attendees will learn how a DMR can assist with compilation and quality assurance review of a DHR – especially for device products with multiple components. It will further help them understand what document control means for DMR documents (records).
Areas Covered in the Webinar:
Who Will Benefit:
Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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